Study Project Manager

Evidilya; Lombardia; Hybride; EUR 28 000 - 35 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Hybrid work model

Onboarding/training

Résumé du poste

Evidilya, the dedicated Contract Research Organization of SPRIM Health Group, is seeking a Study Project Manager to join our Milan team. You will manage all clinical trial and RWE study activities, coordinate the study team and act as the main point of contact between the CRO and sponsors.

You will lead study start-up, ensure TMF/TCF compliance, monitor progress and budgets, and provide regular updates to the BU Director.

Qualifications

• Scientific degree required; ICH-GCP and project management training are a plus.
• Excellent communication, organizational, time-management and decisional skills.
• Knowledge of CTMS and EDC software is desirable.

Responsabilités

• Coordinate all clinical trial and RWE study activities and manage timelines.
• Act as main contact between the CRO and sponsors.
• Lead study start-up, including regulatory submissions and site onboarding.
• Maintain the TMF and Trial Center Files (TCFs).
• Provide updates to the BU Director / Clinical Operations Leader on study status.
• Ensure TMF/TCF compliance with SOPs, ICH-GCP and applicable regulations.
• Support monitoring activities and review monitoring reports.
• Manage the project budget and cost analytics.

Connaissances

Project management

ICH-GCP knowledge

CTMS

EDC software

Communication skills

Organizational skills

Time management

Decision making

Formation

Scientific degree

Outils

CTMS software

EDC software

Description du poste

Evidilya, the dedicated Contract Research Organization of SPRIM Health Group, is a full-service CRO with international expertise in designing and managing observational, pre-clinical and clinical studies in the Food & Nutrition, Pharma and MedTech/Medical Device industries, with a strong technological and digital footprint.

We are looking for a Study Project Manager to join our team in Milan.

• Manage all clinical trial and RWE study activities, planning and prioritizing operational tasks against agreed timelines and coordinating the dedicated study team (Medical Writer, Data Manager, CRA, CTA)
• Act as the main point of contact between the CRO and sponsors (study updates, potential issues, change requests)
• Lead study start-up, including regulatory submissions and approvals, site recruitment and site onboarding
• Draw up and maintain the Trial Master File (TMF) and Trial Center Files (TCFs)
• Provide regular updates to the BU Director / Clinical Operations Leader on study status (vendors, activities, timelines, project plan)
• Ensure TMF/TCF compliance with SOPs, ICH-GCP and applicable regulations, guiding the clinical team on storage and maintenance policies
• Support the clinical team in trial monitoring activities
• Review and approve monitoring reports, ensuring prompt resolution of any issues
• Manage the project budget and cost analytics

Requirements

• Scientific degree (ICH-GCP and Project Management training are a plus)
• Excellent communication, organizational, time-management and decision-making skills
• Nice to have: knowledge of CTMS and EDC software

What we offer

• RAL range: € 28.000 – 35.000, commensurate with experience
• Hybrid working model with 9 remote working days per month and flexible working hours
• Meal vouchers (€ 8 per working day) and a company welfare platform
• A structured onboarding and continuous training programme (ICH-GCP, project management, soft skills)
• Real ownership of your studies from start-up to close-out, working directly with sponsors and the BU Director
• A small, cross-functional team where your contribution is visible and decisions are fast
• Exposure to diverse study types — observational, pre-clinical and clinical — across Food & Nutrition, Pharma and MedTech, with a strong digital and data-driven approach